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Results for “Randomised Controlled Trial”

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PubMed2004

A multicentre randomised controlled trial of an intervention to improve the accuracy of linear growth measurement.

AIMS: To evaluate linear growth assessment and the effect of an intervention on measurement accuracy in primary care practices (PCP) within eight US geographical areas. METHODS: In this multicentre randomised controlled intervention study, paediatric endocrine nurses as site coordinators (SC) visited 55 randomly assigned PCP to evaluate growth assessment of staff performing linear measurements. SC observed 127 measurers assessing a total of 878 children: 307 (baseline), 282 (3 months), and 289 (6 months). Accuracy was determined by SC re-measuring each child with correct technique and equipment. State of the art equipment and a standardised growth training session were provided to the intervention group (IG) following the baseline visit. SC repeated data collection at all PCP at 3 and 6 months. RESULTS: There were no baseline differences between IG and CG equipment, technique, or accuracy; only 30% of measurements were accurate (< or =0.5 cm from SC). Post-intervention, significantly more IG measurements were accurate: IG = 55%, CG = 37% at 3 months; IG = 70%, CG = 34% at 6 months. Odds ratio of accuracy for IG versus CG was 2.1 at 3 months and 4.5 at 6 months. At 6 months, mean difference from the SC measurements was 0.5 cm in IG and 1.1 cm in CG. CONCLUSIONS: In PCP, children are measured inaccurately. Our intervention significantly improved measurement accuracy. Improved accuracy could yield more rapid detection and diagnosis of paediatric growth disorders.

Adolescent↗

PubMed2001

Mega-dose vitamin C in treatment of the common cold: a randomised controlled trial.

OBJECTIVE: To determine the effect of large doses of vitamin C in the treatment of the common cold. STUDY DESIGN: Double-blind, randomised clinical trial with four intervention arms: vitamin C at daily doses of 0.03g ("placebo"), 1 g, 3g, or 3g with additives ("Bio-C") taken at onset of a cold and for the following two days. PARTICIPANTS AND SETTING: 400 healthy volunteers were recruited from staff and students of the Australian National University, Canberra, ACT, between May 1998 and November 1999. The trial continued for 18 months. INTERVENTIONS: Participants were instructed to commence medication when they had experienced early symptoms of a cold for four hours, and to record daily their symptoms, severity, doctor visits and use of other medications. MAIN OUTCOME MEASURES: Duration of symptoms and cold episodes; cumulative symptom severity scores after 7, 14 and 28 days; doctor visits; and whether participants guessed which medication they were taking. RESULTS: 149 participants returned records for 184 cold episodes. No significant differences were observed in any measure of cold duration or severity between the four medication groups. Although differences were not significant, the placebo group had the shortest duration of nasal, systemic and overall symptoms, and the lowest mean severity score at 14 days, and the second lowest at 7 and 28 days. CONCLUSIONS: Doses of vitamin C in excess of 1 g daily taken shortly after onset of a cold did not reduce the duration or severity of cold symptoms in healthy adult volunteers when compared with a vitamin C dose less than the minimum recommended daily intake.

Adult↗

PubMed2006

Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial.

BACKGROUND: Since 1960, oral melphalan and prednisone (MP) has been regarded as the standard of care in elderly multiple myeloma patients. This multicentre randomised trial compared oral MP plus thalidomide (MPT) with MP alone in patients aged 60-85 years. METHODS: Patients with newly diagnosed multiple myeloma were randomly assigned to receive oral MP for six 4-week cycles plus thalidomide (n=129; 100 mg per day continuously until any sign of relapse or progressive disease) or MP alone (n=126). Analysis was intention-to-treat. This study is registered at , number NCT00232934. RESULTS: Patients treated with thalidomide had higher response rates and longer event-free survival (primary endpoints) than patients who were not. Combined complete or partial response rates were 76.0% for MPT and 47.6% for MP alone (absolute difference 28.3%, 95% CI 16.5-39.1), and the near-complete or complete response rates were 27.9% and 7.2%, respectively. 2-year event-free survival rates were 54% for MPT and 27% for MP (hazard ratio [HR] for MPT 0.51, 95% CI 0.35-0.75, p=0.0006). 3-year survival rates were 80% for MPT and 64% for MP (HR for MPT 0.68, 95% CI 0.38-1.22, p=0.19). Rates of grade 3 or 4 adverse events were 48% in MPT patients and 25% in MP patients (p=0.0002). Introduction of enoxaparin prophylaxis reduced rate of thromboembolism from 20% to 3% (p=0.005). CONCLUSION: Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma. Anticoagulant prophylaxis reduces frequency of thrombosis. Longer follow-up is needed to assess effect on overall survival.

Aged↗

PubMed2006

A randomised controlled trial of the effect of biphasic or monophasic waveform on the incidence and severity of cutaneous burns following external direct current cardioversion.

OBJECTIVE: Cutaneous burns are a common cause of morbidity following direct current (DC) cardioversion. We designed a prospective randomised double-blinded controlled study to determine the effect of biphasic or monophasic waveform on the pain and inflammation occurring after elective cardioversion. MATERIALS AND METHODS: One hundred and thirty nine patients undergoing elective DC cardioversion were randomised to receive monophasic (HP Codemaster XL; 100, 200, 300, 360, and 360 J) or biphasic (Welch Allyn-MRL PIC defibrillator; 70, 100, 150, 200, and 300 J) waveforms. Two hours after DC cardioversion, skin temperature, erythema index and sensory threshold to light and sharp touch was measured at the centre and edge of paddle sites. Visual analogue pain score (VAS) was recorded at 2 and 24 h. RESULTS: There was significantly less pain following biphasic cardioversion as assessed by VAS at both 2 h (p < 0.001; 95% confidence intervals of difference of medians (CI) 0.2-0.8 cm) and 24 h (p = 0.004; 95% CI 0.0-0.4 cm). There was significantly less erythema in patients receiving biphasic cardioversion at the edge of the sternal site (p = 0.046; 95% CI 0.41-4.5). There was no difference in any other variable at any site between biphasic and monophasic cardioversion. CONCLUSION: The use of a biphasic waveform for DC cardioversion reduces the inflammation and pain of burns as measured by erythema index and visual analogue scale.

Adult↗

PubMed2005

Intraclass correlation coefficients from three cluster randomised controlled trials in primary and residential health care.

OBJECTIVE: This paper provides intraclass correlation coefficients (ICCs) for estimation of sample size inflation required in future cluster randomised trials in primary or residential care. METHODS: Three cluster randomised trials were conducted among middle-aged and older adults in primary care and residential care in Australia and New Zealand between 1995 and 2002. Baseline means or proportions, mean change, and ICCs with their standard errors and 95% confidence intervals are reported for outcome variables used in the three studies. The ICCs were estimated from a one-way random effects model using the analysis of variance method. RESULTS: ICCs for quality of life and psychological variables in the primary care studies were low (below 0.018). ICCs for clinical and physical activity variables ranged from 0 to 0.08. ICCs for health and functional status in residential care for the elderly were high, ranging from 0.025 to 0.514. CONCLUSIONS: The magnitude of the intraclass correlation varies with the venue of the trial, the outcome variables used, and the expected effect of the intervention. However, the intraclass correlations provided will be useful for more appropriate planning of residential and primary care-based trials in the future.

Adult↗

PubMed2002

A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management.

BACKGROUND: The increase in numbers of patients receiving warfarin treatment has led to the development of alternative models of service delivery for oral anticoagulant monitoring. Patient self management for oral anticoagulation is a model new to the UK. This randomised trial was the first to compare routine primary care management of oral anticoagulation with patient self management. AIM: To test whether patient self management is as safe, in terms of clinical effectiveness, as primary care management within the UK, as assessed by therapeutic international normalised ratio (INR) control. METHOD: Patients receiving warfarin from six general practices who satisfied study entry criteria were eligible to enter the study. Eligible patients were randomised to either intervention (patient self management) or control (routine primary care management) for six months. The intervention comprised two training sessions of one to two hours duration. Patients were allowed to undertake patient self management on successful completion of training. INR testing was undertaken using a Coaguchek device and regular internal/external quality control tests were performed. Patients were advised to perform INR tests every two weeks, or weekly if a dose adjustment was made. Dosage adjustment was undertaken using a simple dosing algorithm. RESULTS: Seventy eight of 206 (38%) patients were eligible for inclusion and, of these, 35 (45%) declined involvement or withdrew from the study. Altogether, 23 intervention and 26 control patients entered the study. There were no significant differences in INR control (per cent time in range: intervention, 74%; control, 77%). There were no serious adverse events in the intervention group, with one fatal retroperitoneal haemorrhage in the control group. Costs of patient self management were significantly greater than for routine care (pound 90 v pound 425/patient/year). CONCLUSION: These are the first UK data to demonstrate that patient self management is as safe as primary care management for a selected population. Further studies are needed to elucidate whether this model of care is suitable for a larger population.

Administration, Oral↗

PubMed2004

Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial.

AIM: To evaluate whether angioplasty or above-knee bypass is the best treatment for symptomatic superficial femoral artery occlusive lesions, we performed a multicentre randomised trial. PATIENTS AND METHODS: Between October 1995 and August 1998, 56 patients were enrolled, all with symptoms related to a 5-15 cm long occlusive lesion of the superficial femoral artery. Thirty-one patients were randomly assigned to percutaneous transluminal angioplasty (PTA); 25 patients to bypass surgery. All patients were followed at 1, 6 and 12 months after the procedure. The primary outcome of our study was re-occlusion of the femoral artery. RESULTS: Thirty patients underwent the allocated PTA and 24 patients underwent bypass surgery. Cumulative 1-year primary patency after PTA was 43 and 82% after bypass surgery. After PTA more than half of the patients had a re-occlusion with an absolute risk reduction of 31% (CI: 6-56%) in favour of bypass surgery. The hazard ratio for occlusion comparing PTA with bypass surgery is 2.24 (95% CI: 0.9-5.58). CONCLUSION: Despite 18 participating centres only 56 patients were randomised to PTA our bypass surgery. Based on our results, for every three patients treated with bypass surgery instead of PTA, one additional re-occlusion is prevented. Therefore, we conclude that with respect to patency, for long superficial femoral artery (SFA) stenoses or occlusions, surgery is better than PTA.

Adult↗

PubMed2006

TTM-based counselling in physiotherapy does not contribute to an increase of adherence to activity recommendations in older adults with chronic low back pain--a randomised controlled trial.

AIMS: The present study examines the outcome of counselling in physiotherapy based on the Transtheoretical Model (TTM) in a sample of elderly individuals with chronic low back pain. METHODS: In a prospective randomised trial with concealed assignment, elderly individuals with chronic low back pain were allocated to two treatment conditions. Both contained 10 sessions of physiotherapy, each of 20min duration. In addition, the experimental group (EG) received 10min counselling prior to every session based on the TTM, also provided by the physiotherapist, and the control group (CG) underwent a placebo ultrasound treatment with an inactivated device to control for the additional attention given to the EG. Assessments took place prior to the treatment (t1), immediately after termination of the treatment (t2), and at a 6-months follow-up. Outcome measures were physical activity calculated from one-week activity diaries, self-reported functional capacity, and range of motion measured by ultrasound topometry. RESULTS: A total of 170 individuals (64% female) with a mean age of 70.3 years (SD=4.4, range 65-84) participated in the study. The retention rate was 90%. At t3, both EG and CG showed increased physical activity and functional capacity, but no change in range of motion. Effect sizes were large. Contrary to our hypothesis, however, motivational training did not result in a better outcome compared with placebo treatment. CONCLUSION: The study does not provide evidence that a short TTM-based motivation programme is superior to placebo treatment regarding adherence to activity recommendations.

Activities of Daily Living↗

PubMed1998

Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Task Force on Postovulatory Methods of Fertility Regulation.

BACKGROUND: A previous randomised study suggested that the progestagen, levonorgestrel, given alone in two separate doses each of 0.75 mg caused nausea and vomiting in fewer women and might be more effective than the Yuzpe regimen of combined oral contraceptives for emergency contraception, although the difference was not significant. We compared these two regimens when started within 72 h of unprotected coitus. METHODS: We enrolled in the double-blind, randomised trial 1998 women at 21 centres worldwide. Women with regular menses, not using hormonal contraception, and requesting emergency contraception after one unprotected coitus, received levonorgestrel (0.75 mg, repeated 12 h later) or the Yuzpe regimen (ethinyloestradiol 100 microg plus levonorgestrel 0.5 mg, repeated 12 h later). FINDINGS: Outcome was unknown for 43 women (25 assigned levonorgestrel, 18 assigned Yuzpe regimen). Among the remaining 1955 women, the crude pregnancy rate was 1.1% (11/976) in the levonorgestrel group compared with 3.2% (31/979) in the Yuzpe regimen group. The crude relative risk of pregnancy for levonorgestrel compared with the Yuzpe regimen was 0.36 (95% CI 0.18-0.70). The proportion of pregnancies prevented (compared with the expected number without treatment) was 85% (74-93) with the levonorgestrel regimen and 57% (39-71) with the Yuzpe regimen. Nausea (23.1 vs 50.5%) and vomiting (5.6 vs 18.8%) were significantly less frequent with the levonorgestrel regimen than with the Yuzpe regimen (p<0.01). The efficacy of both treatments declined with increasing time since unprotected coitus (p=0.01). INTERPRETATION: The levonorgestrel regimen was better tolerated and more effective than the current standard in hormonal emergency contraception. With either regimen, the earlier the treatment is given, the more effective it seems to be.

Adult↗

PubMed2002

Cluster randomised controlled trial of tailored interventions to improve the management of urinary tract infections in women and sore throat.

OBJECTIVE: To assess the effectiveness of tailored interventions to implement guidelines for urinary tract infections in women and sore throat. DESIGN: Unblinded, cluster randomised pretest-post-test trial. SETTING: 142 general practices in Norway. PARTICIPANTS: 72 practices received interventions to implement guidelines for urinary tract infection and 70 practices received interventions to implement guidelines for sore throat, serving as controls for each other. 59 practices in the urinary tract infection group and 61 practices in the sore throat group completed the study. Outcomes were measured in 16 939 consultations for sore throat and 9887 consultations for urinary tract infection. INTERVENTIONS: Interventions were developed to overcome identified barriers to implementing the guidelines. The main components of the tailored interventions were patient educational material, computer based decision support and reminders, an increase in the fee for telephone consultations, and interactive courses for general practitioners and practice assistants. MAIN OUTCOME MEASURES: Changes in rates of use of antibiotics, laboratory tests, and telephone consultations. RESULTS: Patients in the sore throat group were 3% less likely to receive antibiotics after the intervention. Women with symptoms of urinary tract infection in the intervention group were 5.1% less likely to have a laboratory test ordered. No significant differences were found between the groups for the other outcomes. Large variation was found across the included practices in the rates of antibiotic prescription, use of laboratory tests and telephone consultations, and in the extent of change for all three outcome measures. CONCLUSIONS: Passively delivered, complex interventions targeted at identified barriers to change had little effect in changing practice.

Adolescent↗

PubMed2006

Intravenous frusemide for transient tachypnoea of the newborn: a randomised controlled trial.

AIM: To investigate the effect of intravenous frusemide on the course of transient tachypnoea of the newborn (TTN). METHODS: Fifty term infant with TTN were randomised at the time of diagnosis to receive either intravenous frusemide 2 mg/kg or saline placebo. Outcomes assessed included duration of supplemental oxygen requirement, the period of tachypnoea, time to discharge from hospital and weight loss in the first 24 h of life and before discharge. RESULTS: The two groups were similar with respect to sex, birthweight, mode of delivery and age at presentation. The study group lost significantly more weight in the first 24 h after birth. There were no significant differences between the two groups in the duration of oxygen requirements, the period of tachypnoea and the time to hospital discharge. CONCLUSION: A single dose of intravenous frusemide (2 mg/kg) does not improve the clinical course of TTN. This finding suggests that either frusemide is not effective in promoting resorption of lung fluid or factors other than delayed resorption of this fluid contribute to the pathogenesis of TTN.

Diuretics↗

PubMed1996

Randomised controlled trial of effect of high-impact exercise on selected risk factors for osteoporotic fractures.

BACKGROUND: Osteoporotic fractures among the elderly are common, and without preventive measures the burden of these fractures on health-care systems will increase further. The purpose of this randomised controlled study was to evaluate, in premenopausal women, the effects of high-impact loading on several determinants osteoporotic fractures. METHODS: 98 healthy, sedentary female volunteers aged 35-45 years were randomly assigned to either a training (n = 49) or a control group (n = 49). Progressive high-impact exercises were done three times per week for 18 months. We measured bone mineral density (BMD) in specific axial and lower-limb sites, by dual-energy X-ray absorptiometry, at baseline and after 12 and 18 months. Maximum isometric strength, muscular and cardiovascular performance, and dynamic balance were also assessed. FINDINGS: BMD at the femoral neck, a weightbearing site, increased significantly more in the training group (mean 1.6% [95% CI 0.8-2.4]) than in the control group (0.6% [-0.2 to 1.4], p = 0.006). By contrast, at non-weightbearing sites, such as the distal radius, there was no significant difference between the training and control groups (-1.5% [-2.7 to -0.3] vs -0.7% [-1.9 to -0.5], p = 0.60). In the training group there was a significant improvement in vertical jump and predicted oxygen consumption per min at maximum exercise compared with controls. INTERPRETATION: High-impact exercises that load bones with a rapidly rising force profile in versatile movements improve skeletal integrity, muscular performance, and dynamic balance in premenopausal women. If done on a regular basis, this type of exercise may help decrease the risk of osteoporotic fractures in later life. Long-term studies are required to show whether these 18-month results can be translated into long-term benefit.

Adult↗

PubMed2026

Safety Profile of the Non-steroidal Anti-inflammatory Drug Celecoxib in the Short-Term Management of Acute Non-cancer Pain: A Systematic Review with Meta-analysis of Randomised Controlled Trials.

OBJECTIVE: To summarise the literature regarding the safety of short-term use of the non-steroidal anti-inflammatory drug (NSAID) celecoxib. STUDY DESIGN: Systematic review with meta-analysis of randomised trials. Participants comprised individuals of all ages with acute non-cancer pain. Interventions included celecoxib at 200-400 mg/day for up to 10 days. The comparators were placebo, other NSAIDs (including cyclooxygenase-2 [COX-2] inhibitors and non-selective NSAIDS [nsNSAIDS]), or opioids. DATA SOURCES: Five databases were searched from inception to April 2025: Embase, Web of Science, MEDLINE, Cochrane Central Register of Controlled Trials, and Scopus. Additionally, a registry was searched: ClinicalTrials.gov. DATA SYNTHESIS: Meta-analyses using Mantel-Haenszel and random-effects model were used to calculate risk ratios (RRs) and 95% confidence intervals (CIs) for severe cardiovascular, respiratory, and gastrointestinal adverse events and secondary outcomes. The Cochrane Risk of Bias Tool for randomised trials (RoB-2) was used to assess bias risk. The Grading of Recommendation Assessment, Development and Evaluation (GRADE) was conducted to assess the certainty of evidence of each reported outcome. RESULTS: Title/abstract and full text screening comprised 3976 and 273 studies, respectively. Fifty studies were included with 10,693 participants. The RRs for adverse events were no different between celecoxib and placebo for severe events (3 studies) (RR 0.44 [95% CI 0.10-2.03]), cardiovascular (3 studies) (RR 0.84 [95% CI 0.24-2.92]), respiratory (4 studies) (RR 1.23 [95% CI 0.29-5.26]), and gastrointestinal events (33 studies) (RR 0.96 [95% CI 0.64-1.43]). There was no difference between celecoxib and NSAIDS for gastrointestinal adverse events, RR 0.89 (95% CI 0.68-1.17). Celecoxib had a lower risk compared to opioids for gastrointestinal events, RR 0.34 (95% CI 0.14-0.86), and showed a lower risk of nausea compared with placebo, RR 0.75 (95% CI 0.60-0.93), and nsNSAIDS, RR 0.80 (95% CI 0.64-0.99). Most studies had some risk of bias concerns, and the overall certainty of evidence for most outcomes was very low. Celecoxib appears to be safe for acute non-cancer pain when compared to placebo, NSAIDS, and opioids. It had a lower risk compared to opioids for gastrointestinal adverse events in general, nausea and vomiting, as well as a lower risk for nausea adverse events when compared to placebo and nsNSAIDS. REGISTRATION: PROSPERO-CRD42025642152.

Journal Article↗

PubMed2006

Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial.

BACKGROUND: Avian influenza A virus H5N1 has caused widespread infections that have resulted in severe disease or death in poultry and wild birds as well as human beings. This virus has the potential to emerge as a pandemic threat and H5N1 vaccines are being developed in many countries. Our aim was to assess the safety and immunogenicity of an inactivated adjuvanted whole-virion H5N1 vaccine. METHODS: A stratified randomised, placebo-controlled, double-blind phase I clinical trial was done in 120 volunteers aged 18-60 years. Volunteers were assigned to receive two doses of placebo (n=24) or an inactivated whole-virion influenza A (H5N1) vaccine with 1.25 microg (24), 2.5 microg (24), 5 microg (24), or 10 microg (24) haemagglutinin per dose with aluminium hydroxide adjuvant on day 0 and 28. Serum samples were obtained on day 0, 14, 28, 42, and 56 for haemagglutination inhibition and virus neutralisation assays. This trial is registered with the ClinicalTrials.gov registry with the number NCT00356798. FINDINGS: All four formulations of vaccines were well tolerated. No serious adverse event was reported and most local and systemic reactions were mild and transient. All formulations induced antibody responses after the first dose; the highest immune response of 78% seropositivity was seen in the 10 mug group after two vaccine doses. Two individuals dropped out: one in the 1.25 microg group (withdrew consent) and one in the 10 microg group (discontinued); one individual was also excluded from the final analysis. INTERPRETATION: A two-dose regimen of an adjuvanted 10 microg inactivated whole-virion H5N1 vaccine met all European regulatory requirements for annual licensing of seasonal influenza vaccine. Lower doses of this vaccine could achieve immune responses equivalent to those elicited by adjuvanted or non-adjuvanted split-virion vaccines. The use of a whole virion vaccine could be more adaptable to the antigen-sparing strategy recommended by WHO for protection against an influenza pandemic.

Adjuvants, Immunologic↗

PubMed2002

Extracorporeal shock wave therapy for lateral epicondylitis--a double blind randomised controlled trial.

UNLABELLED: Extracorporeal shock wave therapy (ESWT) is an increasingly popular therapeutic approach to the treatment of a number of soft tissue complaints. Whilst benefit has been demonstrated in calcific tendinitis, evidence is lacking for benefit in the management of non-calcific rotator cuff disorders. AIMS: To perform a double-blind placebo controlled trial of moderate dose ESWT in chronic lateral epicondylitis. METHODS: Adults with lateral epicondylitis were randomised to receive either active treatment (1500 pulses ESWT at 0.12 mJ/ mm2) or sham therapy, monthly for three months. All were assessed before each treatment and one month after completion of therapy. Outcome measures consisted of visual analogue scores for pain in the day and at night. RESULTS: Seventy-five subjects participated and there were no significant differences between the two groups at baseline. The mean duration of symptoms was 15.9 and 12 months in the ESWT and sham groups, respectively. Both groups showed significant improvements from two months. No significant difference existed between the groups with respect to the degrees of change in pain scores over the study period. In the ESWT group the mean (SD, range) pain score was 73.4 (14.5, 38-99) at baseline and 47.9 (31.4, 3-100) at three months. In the sham group the mean (SD, range) pain score was 67.2 (21.7, 12-100) at baseline and 51.5 (32.5, 3-100) at three months. At three months, 50% improvement from baseline was noted in 35% of the ESWT group and 34% of the sham group with respect to pain. CONCLUSIONS: There appears to be a significant placebo effect of moderate dose ESWT in subjects with lateral epicondylitis but there is no evidence of added benefit of treatment when compared to sham therapy.

Adult↗

PubMed2004

Effect of aerobic exercise and relaxation training on fatigue and physical performance of cancer patients after surgery. A randomised controlled trial.

Fatigue is a frequent problem after surgical treatment of solid tumours. Aerobic exercise and psychosocial interventions have been shown to reduce the severity of this symptom in cancer patients. Therefore, we compared the effect of the two therapies on fatigue in a randomised controlled study. Seventy-two patients who underwent surgery for lung (n=27) or gastrointestinal tumours (n=42) were assigned to an aerobic exercise group (stationary biking 30 min five times weekly) or a progressive relaxation training group (45 min three times per week). Both interventions were carried out for 3 weeks. At the beginning and the end of the study, we evaluated physical, cognitive and emotional status and somatic complaints with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module (EORTC-QLQ-30) questionnaire, and maximal physical performance with an ergometric stress test. Physical performance of the training group improved significantly during the programme (9.4+/-20 watts, p=0.01) but remained unchanged in the relaxation group (1.5+/-14.8 watts, p=0.37). Fatigue and global health scores improved in both groups during the intervention (fatigue: training group 21%, relaxation group 19%; global health of both groups 19%, p for all < or =0.01); however, there was no significant difference between changes in the scores of both groups (p=0.67). We conclude that a structured aerobic training programme improves the physical performance of patients recovering from surgery for solid tumours. However, exercise is not better than progressive relaxation training for the treatment of fatigue in this setting.

Adult↗

PubMed2003

Randomised controlled trial of single, subacromial injection of methylprednisolone in patients with persistent, post-traumatic impingment of the shoulder.

OBJECTIVE: To evaluate the impact on recovery, of single subacromial injection of methylprednisolone in patients with persistent, post-traumatic impingement of the shoulder. DESIGN: Randomised, controlled study. SETTING: Large accident and emergency department in Leicester, UK. PARTICIPANTS: 98 patients with persistent, post-traumatic impingement of the shoulder. INTERVENTION: Single subacromial injection of methylprednisolone with bupivicaine (group S, n=54) or bupivicaine only (group C, n=44). MAIN OUTCOME MEASURES: Pain using a 10 cm visual analogue scale (VAS) and active shoulder abduction. RESULTS: Comparison of pain scores by the 10 cm VAS between group and group C showed no statistical difference at 3, 6, or 12 weeks. Mean patient pain scores at 12 weeks were 1.38 in both groups (p=0.99). There were 16 patients in group S (mean age 52 years) with a 10 cm VAS greater than 1 (95% CI CI 0.17 to 0.43), compared with 13 patients (mean age 57 years) in group C (95% CI 0.17 to 0.45). Comparison of active shoulder abduction between group S and group C showed no statistical difference at 3, 6, or 12 weeks. Mean active abduction at 12 weeks was 168.9 degrees in group S and 170.3 degrees in group C (p=0.8). There were 10 patients in group S (mean age 60.5) with active abduction less than 170 at 12 weeks (95% CI 0.09 to 0.31), compared with five patients (mean age 62 years) in group C (95% CI 0.04 to 0.24). CONCLUSIONS: Single subacromial injection of methylprednisolone has no beneficial impact on reducing the pain, or the duration of immobility in patients with persistent post-traumatic impingement of the shoulder

Adolescent↗

PubMed1992

Ultrasonic dating of pregnancies: effect on incidence of SGA diagnoses. A randomised controlled trial.

In order to study the incidence of antenatal identification and postnatal diagnosis of small for gestational age (SGA) infants, 4997 women with optimal menstrual history were randomised. One group had the gestational age estimated from last menstrual period (LMP), the other from ultrasonographically measured biparietal diameter (BPD) in the second trimester. Both the incidence of antenatally suspected and postnatally diagnosed SGA infants were reduced by approximately 30% in the BPD-dated group. It is concluded that this was due to the shift in gestational age estimation.

Female↗